Summary: Healgen Scientific’s Rapid Check COVID-19/Flu A&B Antigen Test received FDA De Novo authorization for over-the-counter use, providing a fast, reliable solution for detecting COVID-19, influenza A, and influenza B at home.

Takeaways:

  1. The FDA’s De Novo authorization highlights the success of Healgen’s test, providing a convenient at-home diagnostic solution for COVID-19, flu A, and flu B with greater than 90% sensitivity and 99% specificity.
  2. The test’s development was supported by NIH’s RADx Tech program and ITAP, showcasing its reliability and accuracy for individuals aged 14 and above, or children with adult supervision.
  3. Healgen plans to scale up production to meet global demand for respiratory testing during the upcoming flu season, offering a simple nasal swab method for quick diagnosis.

Healgen Scientific announced the U.S. Food and Drug Administration (FDA) granted De Novo marketing authorization for Healgen Rapid Check COVID-19/Flu A&B Antigen Test for over-the-counter (OTC) use. 

The FDA’s De Novo pathway is designed for medical devices that do not have legally marketed comparison device and is a unique opportunity for development of a new device classification that can improve patient care and outcomes.

The Rapid COVID-19/Flu A&B Antigen Test

The OTC Healgen Rapid Check COVID-19/Flu A&B Antigen Test provides rapid, accurate and convenient detection of COVID-19, influenza A and influenza B infections. 

“Our combo test addresses a critical gap in clinical diagnostic testing by providing a reliable and user-friendly solution for individuals to test themselves at home,” says Bingliang Fang, MD, PhD, CEO of Healgen. “Early diagnosis enables faster initiation of appropriate treatment, leading to improved health outcomes and reduced disease transmission.”

Validation of Healgen’s at-home test data was supported through the Independent Test Assessment Program (ITAP), part of National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program. ITAP assessed Healgen’s Rapid Check COVID-19/Flu A&B Antigen Test’s quality, accuracy and reliability, and found it demonstrated sensitivity and specificity of greater than 90% and 99%, respectively. 

“This De Novo marketing authorization for Healgen highlights the success of the RADx Tech program and ITAP in speeding the authorization of home-based tests, and will be an important part of the public health toolkit as we move into the fall respiratory virus season,” says Rebekah Neal, VentureWell VP for Ccmmercialization. “VentureWell is proud to have played a role in this collaboration as the NIH/NIBIB Innovation Funnel Commercialization Center.”

Simple Nasal Swab Test

With a simple nasal swab, individuals can quickly determine whether their symptoms are due to COVID-19, Influenza A or Influenza B. This eliminates the need for multiple tests and reduces the burden on health care systems. The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is authorized for individuals aged 14 years or older, or adult-collected samples from individuals aged 2 years or older, who are experiencing symptoms within the first five days.

“This De Novo authorization represents a significant milestone for Healgen. With our existing state-of-art manufacturing facility, we plan to scale up production of our respiratory tests to meet the global demand for the upcoming fall respiratory season,” says Bryan Fang, president of Healgen.

Further Reading: Healgen Scientific Opens Houston Facility to Bolster COVID-19/Flu Test Production

The Healgen Rapid Check COVID-19/Flu A&B Antigen Test has been designed to meet the highest performance standards, including accuracy, reliability, and ease of use, ensuring that individuals can trust the results they receive, says Healgen.

This project has been partly funded with federal funds from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract Nos. 75N92022D00010 and 75N92022D00013.

Photo: Healgen